Phase | Pre-randomization | Post-randomization | Post-trial | ||||
---|---|---|---|---|---|---|---|
Time point | Enrollment | Allocation | week 1 | week 8 | week 11 | week 19 | week 52 follow-up |
Enrollment | x | ||||||
Clinical assessment (including DSM-IV diagnosis by treating medical practitioner) | |||||||
Eligibility screen | x | ||||||
Informed consent | x | ||||||
Randomization | x | ||||||
Allocates sequence of modules: | |||||||
AB or BA | |||||||
1st Module |
| ||||||
2nd Module |
| ||||||
Primary assessments: | x | x | x | x | x | ||
Functioning - SOFAS and FAST | |||||||
Symptoms - SPHERE12 | x | x | x | x | x | ||
Disability - BDQ | |||||||
Self-esteem - RSEQ | |||||||
Vocational status: | x | x | x | ||||
Education, employment, receipt of benefits, etc. | |||||||
Engagement with intervention: | x | x | |||||
Number of sessions attended | |||||||
Secondary assessments: | x | x | x | x | x | ||
Levels of distress - K-10 | |||||||
Social well-being - WHOQOL | |||||||
Physical health/Lifestyle: | x | x | x | x | x | ||
Sleep profile - PSQI | |||||||
Exercise/Activity profile - IPAQ | |||||||
Tobacco and substance use - ASSIST | |||||||
Other measures: | x | x | x | x | x | x | |
Anthropometrics: | |||||||
BMI, body weight, waist circumference | |||||||
Metabolic screen and other blood tests: | x | x | x | ||||
Lipids, fasting glucose, FBC, LFTs, etc. |